AccessGUDID - DEVICE: Boston Keratoprosthesis Lucia Type I (00862395000214)

GUDID

Device Identifier (DI) Information

Brand Name: Boston Keratoprosthesis Lucia Type I
Version or Model: L-T1A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L-T1A
Company Name: Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.

Primary DI Number: 00862395000214
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073825945 *Terms of Use

Device Description: Boston Keratoprosthesis Lucia Type 1 Aphakia with anodized Titanium back plate 7.8 mm BR (Brown ); BL (Blue)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42525	Cornea prosthesis	An implantable artificial substitute for a natural cornea used to improve/restore the vision of an adult patient with corneal opacity. Also known as a keratoprosthesis, this is usually a two-component device made of, e.g., poly 2-hydroxyethylmethacrylate (PHEMA), one component being a small fine threaded flange that is attached to the anterior of the eye and the other being the lens, which is a solid cylinder of this material, threaded at the distal end and convex at the proximal end. This lens is threaded into the flange proving the user with a window through which he or she can see. This device may be used when other interventions are not possible.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HQM	Keratoprosthesis, Permanent Implant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182986	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df2dc9fc-b996-4c32-b326-b16cf9676c36
Public Version Date: October 12, 2021
Public Version Number: 1
DI Record Publish Date: October 04, 2021